FGF-21 and Exercise in Relation to Insulin Secretion | NCT02667964

Studies
FGF-21 and Exercise in Relation to Insulin Secretion

NCT02667964

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Jan 29, 2016Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Physical Activity

Interventions

spiroergometry

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Nov 24, 2015

First Submission Date that Met QC Criteria

Jan 26, 2016

First Posted Date

Jan 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Knut Mai, FGF-21 and Exercise, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

FGF-21 and insulin are key hormones in the regulation of glucose metabolism. Furthermore, both hormones are influenced by physical activity. The following hypothesis will be tested: FGF-21 is regulated insulin-dependent during exercise.

Detailed Description

Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by rising global importance. In Germany alone, more than seven million people are being treated currently. T2DM is characterized by permanently elevated blood glucose levels, based on insulin resistance and followed by associated beta cell failure. In our previous work the investigators could already shown that increased FGF-21 levels are accompanied by an increased risk of T2DM. Physical activity is essential in the treatment and the prevention of T2DM. Interestingly, it was shown that acute physical exercise was leading to decreased insulin levels and increased FGF-21 values. In this study the effects of acute physical activity on FGF-21 values should be investigated in 3 groups: a) Healthy volunteers b) persons with T2DM c) persons with T1DM.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy controls	Other	Spiroergometry	Other: spiroergometry
Patients with T2DM	Other	Spiroergometry	Other: spiroergometry
Patients with T1DM	Other	Spiroergometry	Other: spiroergometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spiroergometry	Other	Spiroergometry on a bicycle ergometer	Healthy controls Patients with T1DM Patients with T2DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FGF-21 change after physical activity		FGF-21 before and 1 h after spiroergometry

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers,persons with T2DM, persons with T1DM

Exclusion Criteria:

Patients with contraindications to an exercise ECG or spirometry be excluded from participation in the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Bobbert, Dr.	Contact	450514252	030	thomas.bobbert@charite.de

Overall Officials

Name	Affiliation	Role
Thomas Bobbert, Dr	Charité	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité	Recruiting	Berlin	State of Berlin	10117	Germany